The Effect of Sertindole and Risperidone on Endophenotypic Markers of Schizophrenia

NCT02021201 | Terminated Phase 4 DMC

• 1 other identifier: H-A-2008-062
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This comparison is made between the effects of sertindole and risperidone on vulnerability indicators in schizophrenia. More specifically: the effects of these two antipsychotic compounds on basic processing of incoming information is studied. The investigators expect that the newer antipsychotic sertindole to be more effective in restoring information processing in schizophrenia patients than risperidone.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Psychophysiological parameters sensory gating

  baseline, after ten weeks and after 20 weeks

Secondary Outcomes (2)

• Psychophysiological parameters of selective attention

  Baseline, 10 weeks and 20 weeks after treatment

• Neurocognitive parameters of amongst others executive functioning, attention, and reaction time

  10 weeks and 20 weeks after treatment

Study Arms (2)

1

EXPERIMENTAL

Patients with schizophrenia will be treated with risperidone or sertindole for a period of 10 weeks, after which they will cross-over for an additional treatment of 10 weeks with the other compound

Drug: risperidone; Drug: Sertindole

2

EXPERIMENTAL

Patients with schizophrenia will be treated with risperidone or sertindole for a period of 10 weeks, after which they will cross-over for an additional treatment of 10 weeks with the other compound

Drug: risperidone; Drug: Sertindole

Interventions

risperidone DRUG

Patients with schizophrenia will be treated for 10 weeks treatment with risperidone

Also known as: Risperdal

1; 2

Sertindole DRUG

Patients with schizophrenia will be treated for 10 weeks treatment with serindole

Also known as: Serdolect

1; 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy controls:
• matched by age (+/- 2 years), gender and parental socioeconomic status to patients with schizophrenia.
• age between 18-55 years
• male
• physically and mentally healthy and no daily intake of medicine
• no current substance abuse
• Patients:
• patients who fulfill both ICD-10 and DSM IV diagnostic criteria for schizophrenia.
• age between 18-55 years
• male
• patients who need a change in their medication
• diagnosed with schizophrenia within the last 10 years
• not formerly treated with risperidone (Risperdal) or sertindole (Serdolect) where treatment was stopped because of side effects or lack of effect
• physically healthy
• no current substance abuse

You may not qualify if:

• Controls:
• a history of mental illness in the first degree relatives
• hearing disabilities
• head injury accompanied by unconsciousness for more than 5 min.
• physical illness with a need of daily intake of medicine
• positive screening for drugs of abuse at baseline.
• Patients:
• head injury accompanied by unconsciousness for more than 5 min.
• serious medical conditions (more specific: brain diseases and diseases which cause a daily intake of medicine, heart, liver or kidney diseases, diabetes and prolongation of the QTc-interval (or a family history of such) and patients with phenylketonuri)
• abuse of alcohol or medication/ narcotics during the last 6 months or positive screening for drugs of abuse at baseline.
• former treatment with risperidone (Risperdal) or sertindole (Serdolect) where treatment was stopped because of side effects or lack of effect
• hearing disability
• allergy towards the content in the medicine used in the study
• bradycardia (pulse under 50 beats per minute) and QTc\>450 ms

Sponsors & Collaborators

• Birte Glenthoj: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup

Glostrup Municipality, DK-2600, Denmark

Location

Related Links

• Homepage of our organization

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone; sertindole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Birte Y Glenthoj, PhD

  Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup

  STUDY DIRECTOR

• Bob Oranje, PhD

  Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup

  PRINCIPAL INVESTIGATOR

• Birgitte Fagerlund, PhD

  Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup

  PRINCIPAL INVESTIGATOR

• Rita S Godske, MD

  Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Psychiatric Center Glostrup

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: December 27, 2013
• Study Start: July 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

DK (1)